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Author Topic: Deep brain stimulator - Extension  (Read 63733 times)
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dennis100
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« Reply #210 on: August 08, 2015, 07:52:14 AM »

Model Number 37612
Event Date 06/09/2015
Event Type Injury
Manufacturer Narrative
Final analysis of one of the leads with lot v014246 revealed the outer insulation was breached 33 centimeters from the distal end. Analysis of the other lead with lot v014246 revealed no significant anomalies. The lead body was cut through and segmented. Final analysis of extension (b)(4) revealed no significant anomalies.

Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# v014246, implanted:(b)(6) 2007, product type: lead. Product id: 64002, lot# n318565, implanted: (b)(6) 2012, product type: adapter. Product id: 3387s-40, lot# v014246, implanted: (b)(6) 2007, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 748251, serial# (b)(4), implanted:(b)(6) 2007, explanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, explanted:(b)(6) 2015, product type: extension. Product id: neu_burrholecap, product type: accessory. Product id: neu_burrholering, product type: accessory. Product id: 3550-29, product type: accessory. Product id: 3387s-40, lot# v014246, implanted: (b)(6) 2007, product type: lead. Product id: neu_stimloc_acc, product type: accessory. (b)(4). Analysis results were not available as of the date of this report. A follow-up report will be submitted when analysis is complete.

Event Description
It was reported there was protrusion of the right extension on the head near the ear due to lead explant. The right lead was explanted and detached from the extension left at the time of lead explant. Upon inspection in the emergency room inflammation and infection was noted for the extension. The type of infection was unknown. The event required a hospital emergency room visit which resulted in admission. A cat scan was performed and swelling over the extensions was noted. The entire system was explanted as an intervention. The event was recovered with sequelae.

Manufacturer Narrative
Previously the event was noted as a malfunction. Supplemental has been sent to update to serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889156
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dennis100
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« Reply #211 on: August 08, 2015, 07:52:57 AM »

Model Number 3708640
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the extension was broken or damaged during tunneling at the implant procedure. It was unknown what caused the damage. The extension was replaced with a new one during the same procedure and was functioning well. The issue was resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4940336
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dennis100
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« Reply #212 on: September 07, 2015, 06:50:18 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 37085-40, serial# (b)(4), product type: extension. (b)(4).

Event Description
The health care provider (hcp) reported via the manufacturer's representative that high impedances were measured on lead contact 3. The high impedances occurred because a replacement of the system was performed at a clinic inexperienced with deep brain stimulation and the extension was incorrectly connected to the header block of the implantable neurostimulator (ins). It was noted the extension was also accidentally cut during the replacement. A revision surgery occurred. The hcp was unable to disconnect the extension from the header block. The ins and two extensions were replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5036331
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dennis100
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« Reply #213 on: September 07, 2015, 06:51:03 AM »

Model Number 3708660
Event Date 07/12/2015
Event Type Malfunction
Event Description
The healthcare provider (hcp) reported the extension connector's plastic housing started to shear/be cut through. The issue occurred after the extension was placed in the extension carrier. It was stated that "as they advanced the carrier through the tunneler to lock into place, part of the extension rubbed on the entry of the tunneler and caused a cut into the plastic of the connector. " a visual inspection of the extension was performed at that time and a "cut in the plastic" was observed on the connector. The extension was not implanted and was instead replaced as a result of the event and the issue was resolved. It was noted there were "no issues with the extension and no issues with impedances post-operatively. " there was no surgical intervention planned or undertaken due to the event. The patient was alive with no injury at the time of report. A supplemental report will be filed if additional information is received.

Manufacturer Narrative
(b)(4). Device evaluation: analysis of the extension found the molded rubber on the extension¿s distal end was cut.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4965070
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dennis100
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« Reply #214 on: September 07, 2015, 06:51:41 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 8840, product type: programmer, physician. Product id: 3387s-40, lot# v605118, implanted: (b)(6)2011, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6)2014, product type: extension. Product id: 3387s-40, lot# v605118, implanted: (b)(6) 2011, product type: lead. Product id: 3387s-40, lot# v605118, implanted: (b)(6) 2011, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

Event Description
A manufacturing representative reported the patient¿s lead and extension connection eroded through their skin. The patient had symptoms of itching. Relevant medical history included parkinson¿s disease and movement disorders. The extension and lead connection was surgically buried to resolve the erosion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976919
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dennis100
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« Reply #215 on: September 07, 2015, 06:52:32 AM »

Model Number 37603
Event Date 07/22/2015
Event Type Malfunction
Manufacturer Narrative
Concomitant products: product id: 3708660, serial# (b)(4), product type: extension. Product id: 3389s-40, lot# va0wjgz, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3389s-40, lot# va0wjgz, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4). Analysis of the extension (s/n (b)(4)) found the conductor #2 was broken 2. 8cm from the proximal end. (b)(4).

Event Description
The manufacturer's representative reported that during procedure, high impedances >40,000 ohms was seen on contact 2. The extension was tested several times with the same result. Intraoperative testing with the clinician programmer identified the issue. Connections were cleaned at the battery and lead interfaces but there was no change in impedance values on contact 2. The lead was also tested to ensure there was no damage. The extension was replaced and the impedance values normalized. The issue resolved at the time of this report. No further information was provided. If additional information is received, a followup report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5003920
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dennis100
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« Reply #216 on: September 07, 2015, 06:53:24 AM »

Model Number 37601
Device Problem High impedance
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 748251, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 3708660, serial# (b)(4), product type: extension. Product id 748251, serial# (b)(4), product type: extension. Product id 64002, product type: adapter. Product id 3550-29, product type: accessory. (b)(4). Device evaluation: analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 23. 2 cm from the distal end. ¿ analysis of extension (b)(4) found ¿the extension was fine electrically but conductor #3 was exposed at a breached depression on the outer insulation at 47. 0 cm from the distal end. ¿ analysis of extensions (b)(4) and (b)(4) and the pocket adapter found no anomalies.

Event Description
The patient's physician reported the patient "felt electrifying pain near the implantable neurostimulator (ins) and toward poor in the right side. " it was noted this had occurred following an ins replacement with an ins and pocket adapter, though initially following the replacement "everything was ok. " the patient reported they felt increasing electrical pain in the area of the ins with the pain radiating into their arm following the replacement. Initial impedance testing performed after the implant of the ins and adapter found "normal" impedances. Impedance testing performed at the time of report found the impedances were "too high" to be measured. The patient's physician performed troubleshooting through a revision procedure as a result. First, the physician changed the patient's pocket adapter, with "no improvement of the impedances. " the physician then changed the patient's extensions ((b)(4) and (b)(4)), "but with the new extensions the impedances were not measureable, so the physician changed the new extensions ((b)(4) and (b)(4)) again with two new extensions. " the impedances for contacts 0 and 8 reportedly remained not measurable at that time. It was reported the second pair of replacement extensions remained implanted at the time of report and the patient was "well" and "got an effective therapy" from their device. The physician was to be followed-up with a week after initial report. A supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5004520
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dennis100
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« Reply #217 on: September 07, 2015, 06:54:10 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/28/2015
Event Type Injury
Event Description
A health care provider reported via a manufacturing representative that high impedances were measured during intraoperative testing. The extensions were removed from the implantable neurostimulator (ins), placed in opposite ins channels, and then placed back in their original channels. After moving the extensions around, the impedance issue seemed to be resolved. A week after implant, impedance of contact nine was measured to be above 40,000 ohms. A revision was done and the extensions were disconnected from the ins and switched around. Impedances were then measured to be normal. The extensions were then switched to their original position and impedance was measured to be high on contact nine again. The manufacturing representative had expected contact one to have high impedance following the swap. The extensions were removed again, cleaned and reinserted into the ins. Impedances were then measured to be normal. The issue was resolved at the time of this report.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5014521
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dennis100
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« Reply #218 on: September 07, 2015, 06:54:53 AM »

Model Number 7428
Event Type Injury
Manufacturer Narrative
Product id: 7482-51, serial# (b)(4), product type: extension. Product id: 7482-51, serial# (b)(4), product type: extension. (b)(4).

Event Description
The health care provider (hcp) reported via the company representative (rep) that the implantable neurostimulator (ins) and extensions were migrating through the patient's skin wall. The migration has been so great that the corner where the extensions go into the header block were visible on the outside of the patient. There was some infection at the site where the skin was broken. The patient was extremely thin, which led to this event. This has happened before to the patient and it was thought there has been a long standing infection. Pre and post op impedance tests were performed. The surgeon resected the infected skin and implanted the ins deeper under the small amount of remaining breast tissue. The infection required long term antibiotics, surgical wound. The issue was resolved at the time of the report. The hcp has no further information for the device manufacturer. The relevant medical history included parkinson's disease and low body weight. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027730
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dennis100
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« Reply #219 on: September 07, 2015, 06:55:38 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/24/2015
Event Type Injury
Event Description
The health care provider reported via the company representative that low impedances were measured on the left side electrodes. The pocket adaptor was changed, but the impedances were still low. During surgery, impedances were measured on the left lead and electrode and found to be 19 ohms on electrode 0/2 and 23 ohms on 0/3. Right side impedances were normal. The extension was disconnected and the lead impedances were measured. Impedances were then normal. The extensions were replaced and all impedances were then normal. The issue was resolved.

Manufacturer Narrative
Concomitant: product id 7482-51, serial# (b)(4), implanted: 2007-(b)(6), explanted: 2015-(b)(6), product type extension. Product id 7482-51, serial# (b)(4), product type extension. (b)(4). Analysis of extension model 7482-51, sn: (b)(4), found no anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5029660
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